Ann Thorac Surg 2006;81:1185-1188
© 2006 The Society of Thoracic Surgeons
Ethics in cardiothoracic surgery
Ethics Guidelines for Destination Therapy
Denise M. Dudzinski, PhD, MTS
*
University of Washington Medical Center, University of Washington School of Medicine, Seattle, Washington
* Address correspondence to Dr Dudzinski, University of Washington Medical Center University of Washington School of Medicine, A204 HSC, Box 357120, Seattle, WA 98195-7120 (Email: denise.dudzinski{at}u.washington.edu).
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Abstract
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The introduction of the left ventricular assist device as a destination therapy for patients with heart failure introduces several ethical issues. These issues are discussed to help destination therapy teams design ethically sound policies and procedures. This article addresses ethical issues pertaining to informed decision making, device failure, and change out, as well as guidelines for deactivation, fair employment of medical and psychosocial criteria, the nature of destination therapy as an elective end-of-life therapy, and advance care planning strategies.
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Introduction
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The Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial demonstrated the efficacy of left ventricular assist devices (LVADs) for patients with end-stage heart failure who are not eligible for transplantation because of advanced age or comorbidities. The LVAD became a destination therapy (DT) for these patients [1]. Assuming reverse remodeling does not occur, DT is an end-of-life therapy, not a curative therapy, that may improve the quality and duration of life for select patients. Because all DT patients have incurable heart failure refractory to standard treatment, the benefit of DT hinges on how patients want to live the last months of their lives and which treatments allow them to best pursue their life goals.
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Fair Patient Selection
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Destination therapy is available for patients with chronic end-stage heart failure who are not candidates for heart transplantation and meet specific medical criteria described elsewhere [2]. Left ventricular assist devices are expensive but not scarce resources; therefore teams should consider whether there are compelling medical reasons to deny patients DT based on poor diet, tobacco, or recreational alcohol or drug use. Still some patients may be disadvantaged such as those living in rural areas without access to paramedics, cognitively disabled, and those isolated without social support or without insurance. Standards are best established that make allowances for these disadvantages without subjecting patients to a treatment for which they are ill prepared to manage at home.
There are three ethical considerations concerning patient selection. (1) Inclusion and exclusion criteria should be clearly outlined in writing, justified with explicit rationale, and discussed frequently with patients during evaluation. Strict and fairly applied standards for patient selection ensure that the treatment benefits will be maximized and harms minimized. (2) Special care should be taken to ensure that medical criteria are supported by the most current medical evidence and are consistently and fairly applied. (3) Reliable data about need, costs, and outcomes, some of which are available through the International Society for Heart and Lung Transplant's Mechanical Circulatory Support Database, should be the foundation of decisions to expand or discontinue a program [3, 4].
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Informed Decision Making
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Informed decision making is the patient's willing and voluntary acceptance of a medical intervention after ongoing discussion with the physician about the nature of the intervention as well as the risks and benefits of the recommended treatment and treatment alternatives.
The physician is responsible for discussing the following issues with patients and their families. Many of these issues are discussed in more detail in this article. (1) Treatment options and their implications for each patient, including continued medical management, palliative care, and destination therapy. (2) The goal of treatment as an innovative surgical intervention designed to improve the quality of the final months of a patient's life. Hence, all patients receiving LVADs as a bridge to transplant should also be informed of the possibility that the goal of treatment will shift to DT if co-morbidities subsequently preclude them from transplantation. (3) Advance care planning, which includes discussion of the patient's preferences in the event of complications that would reasonably lead to deactivation of the LVAD. (4) Various scenarios delineating what a patient's day-to-day life might be like perioperatively and post-implantation, including talking with an LVAD patient. (5) Guidelines for deactivating the LVAD, including a description of how the patient's pain and symptoms will be relieved before, during, and after deactivation. (6) Criteria for and rate of device change out (DCO), including discussion of scenarios when DCO would not be offered. (7) Rate of device malfunction and system failure with discussion of what the patient will experience during typical failures and demonstration of emergency response procedures.
Emergent DT evaluation, in which evaluation is rushed to prevent imminent death, compromises informed consent. Therefore it is inadvisable given that DT is an elective, noncurative end-of-life therapy. Since half of all patients diagnosed with heart failure die within 5 years of diagnosis, the preferences for resuscitation and treatment limitations are best discussed early with all heart failure patients [5]. Patients who lack capacity to voluntarily consent should not be offered DT because they are unable to weigh benefits and burdens, and alternative end-of-life therapies are less burdensome. As transplant teams acquire more experience and as the devices improve, the possibility of surrogate consent, in which the patient designates someone to make decisions on their behalf if they lose decision-making capacity, should be revisited.
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Treatment Options
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Patients eligible for DT have three treatment options. First, patients may choose destination therapy now with the understanding that palliative care will be appropriate at some later time (when the device fails, after another life-threatening event such as stroke or infection, or when the patient chooses to discontinue LVAD support). Second, patients may choose to continue medical therapy with the understanding that palliative care will be appropriate in the future. Third, patients may choose palliative care alone. Palliative therapies aim not at cure or extension of life but at relieving pain and symptoms to maximize patient comfort. Unless the patient suddenly dies, the benefits of DT will gradually diminish either because the patient's quality of life will diminish (eg, due to comorbidities) or because the device fails. Frequent discussion of all three options is the foundation of informed decision making and insures that the patient does not feel abandoned if the patient decides against DT (see Fig 1).
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Fig 1. Flow chart outlining key decision points for destination therapy. (DCO = device change out; DT = destination therapy; IC = informed consent; LVAD = left ventricular assist device; MT = medical therapy; PC = palliative care; Pt = patient; Tx = transplant.)
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Quality of Life
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The medical risks and benefits have been delineated elsewhere [1, 2, 6, 7]. Surveys of LVAD patients during the course of a year found that many patients were satisfied with life overall. Symptoms such as weakness, anxiety, and feelings of helplessness persisted during the year, but physical functional disability and disability related to home management, recreation, and work decreased [1, 7, 8]. However, benefits such as extending life, improving mobility, exercise tolerance, and functional status must be balanced against risks of malnutrition, events of thromboembolism, infection and sepsis, device malfunction, decreased cardiac function, organ failure, right ventricular failure, and physiologic complications. Patients with LVADs are also more than twice as likely to suffer adverse events as medically managed patients, with risk of complications increasing the longer the device is implanted [1, 7]. All DT patients should have the option to discontinue LVAD therapy when burdens outweigh benefits.
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Advanced Care Planning
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Advance care planning is a routine part of psychosocial assessments [9]. Patients designate a surrogate decision maker and explore their values, goals, and treatment preferences in the event that they are unable to speak for themselves. Patient preferences are documented in the medical record and in advance directives such as living wills [10]. The following questions elicit patient preferences. What goals do you hope to achieve? What burdens and experiences do you want to avoid? How can DT, medical therapy, or comfort care help you achieve those goals?
Through advance care planning, the DT team helps the patient and family realistically envision the transition from more aggressive management to a future comfort care plan [9, 10]. Explicit scenarios should be discussed with patients and their families to elicit patient preferences and inform the patient of the physician's professional obligations and ethical judgments. For example, the physician may tell the family that in the event of profound neurologic injury, the surgeons will recommend deactivating the device to allow for a natural death. The rationale for deactivation is that the patient cannot appreciate the benefits of continued aggressive therapy and will only experience the burdens. Likewise deactivation and referral to hospice would be recommended if irreversible hepatic and renal injury required indefinite care in the intensive care unit. In such cases, it is often reasonable to continue interventions on a short-term basis (such as time trials) to help the patient prepare to shift to palliative care. Ethics consultation and palliative care services can offer assistance.
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Guidelines for Deactivating the LVAD
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The Patient Self-Determination Act protects a patient's right to withhold or withdraw medical therapy so that a natural death may occur. A natural death can occur by deactivating the LVAD, due to device failure, due to co-morbidities, or due to progression of disease.
The LVAD may be deactivated in two ways. First, the DT team can help patients disconnect the power source in the context of excellent comfort care. Blood flow through the LVAD stops and pooling may lead to thrombosis or regurgitant flow of blood through the device that may impede the functioning of the rest of the heart [10]. Deactivation is not euthanasia because the therapeutic goal is patient comfort, not hastened death. Generally, withdrawal of specific treatments is justified if they no longer meet the patient's or treatment goals or no longer produce a benefit [10, 11]. Still, concern about the ethical permissibility of turning off implanted devices is understandable [12]. Because the patient's heart was already severely damaged prior to implantation of the device, the patient's death is due to underlying cardiac disease just as when the ventilator is withdrawn, the patient dies of impaired lung function [13]. It is the patient or surrogate's assessment of what is beneficial that dictates the ethical permissibility of deactivation.
The second option, surgical removal of the LVAD, is more complicated. Not only is surgery invasive and likely to cause the patient's death, it also compromises the patient's comfort, which is often the new goal of therapy. This is an ethically justifiable reason to refuse to operate. The DT team could develop a policy not to surgically remove the LVAD unless exceptional circumstances arise in which the harm of keeping the LVAD outweigh the risks of explantation. The deactivation policy should be discussed prior to LVAD surgery to insure informed decision making.
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Device Malfunction and Failure
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System failure and device malfunction are frightening and life-threatening. The second leading cause of death after sepsis is device failure. The device malfunction rate is as high as .77 per patient per year. Malfunctions of the implantable portions are life-threatening and accounted for 57 deaths in the REMATCH study [7]. Transplant teams already strive to meet ethical obligations to educate patients, families, and local paramedics about LVAD maintenance, alarm recognition, trouble shooting, use of the pneumatic device, and modified resuscitation techniques. The team's second obligation is to inform patients of the high likelihood of device malfunction or failure, what they are likely to experience as a result, and their preferences in the event of system failure or malfunction.
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Device Change Out
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Twenty-three REMATCH patients received a total of 29 devices and at 2 years out, 63% of patients had the device replaced [7]. Given the high probability that a DCO will be necessary, criteria for DCO should be documented and discussed with patients prior to first implantation. When is DCO medically beneficial and when is it futile or harmful? There are two possible positions. First, DCO is permissible as long as the patient meets medical criteria (beneficence balanced with nonmaleficence) and wants it (respect for autonomy). Second, there are reasonable limits on the number of DCOs in consideration of allocation of the time and resources of the DT team (justice). Ideally, a compromise between the two could be reached (eg, when one device change out is permitted provided the benefits outweigh the risks from both the medical and patient perspectives). Improvements in the device may also reduce the frequency of DCOs. This complex issue requires ongoing discussion. Collaboration with an ethics consultant can be helpful.
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Justice
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Justice concerns the fair and equitable distribution of health care resources. Justice balances fair delivery and access to services with fair restriction of services. Destination therapy increases patient access to aggressive heart failure management and addresses inequities in treatment options among patients with chronic heart failure, particularly among elderly patients [14]. Improvements in the device may allow more people to benefit and may minimize the incidence of device failure [7]. However, resources devoted to DT may be better allocated to less technologically sophisticated surgeries that help greater numbers of patients, such as coronary artery bypass surgeries. Institutions should also consider providing charity care for a portion of patients even though doing so will be expensive. Finally, as trials comparing pulsatile and continuous flow pumps continue, programs should ensure equipoise between the two arms of the trial and eventually opt for the devices most likely to expand the pool of eligible patients and minimize risks and adverse events.
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Comment
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In conclusion, DT raises ethical issues that are likely to become more complex as DT teams gain experience and we have more information about patients' experiences. When DT teams make ethical issues prominent in their daily work and programmatic development, informed decision-making improves, justice and respect for autonomy are balanced, and end-stage heart failure patients are supported through the end of their lives [15].
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Acknowledgments
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The author thanks the heart transplant team at the University of Washington Medical Center for inviting her to think through these issues with them.
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References
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- Bond AE, Nelson K, Germany CL, Smart AN. The left ventricular assist device Am J Nurs 2003;103(1):32-40.[Medline]
- Rose EA, Moskowitz AJ, Packer M, et al. The REMATCH trialrationale, design, and end points. Ann Thorac Surg 1999;67(3):723-730.[Abstract/Free Full Text]
- Park SJ, Joyce LD, Liao KK, et al. Will device change-out be inevitable in destination therapy? J Heart Lung Transplant 2004;23(2 Suppl 1):S63-S64.
- Deng MC, Edwards LB, Hertz MI, et al. Mechanical circulatory support device database of the International Society for Heart and Lung Transplantationthird annual report–2005. J Heart Lung Transplant 2005;4(9):1182-1187.
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- Bramstedt KA, Wenger NS, McGregor M, et al. When withdrawal of life-sustaining care does more than allow death to take its coursethe dilemma of left ventricular assist devices. J Heart Lung Transplant 2001;20:544-548.[Medline]
- Force ET. Consensus report on the ethics of foregoing life-sustaining treatments in the critically ill Crit Care Med 1990;18:1435-1439.[Medline]
- Paola F, Walker R. Deactivating the implantable cardioverter-defibrillatora biofixture analysis. South Med J 2000;93:20-23.[Medline]
- Powell TP, Oz MC. Discontinuing the LVADethical considerations. Ann Thorac Surg 1997;63:1223-1224.[Free Full Text]
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- Rose EA, Gellins A, Moskowita A, et al. Long-term use of a left ventricular assist device for end-stage heart failure NEJM 2001;325(20):1435-1443.
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Abstract
Introduction
